{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160729",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "46455",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208401Orig1s000_toc.html",
              "date": "20161221",
              "type": "Review"
            },
            {
              "id": "10654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208401Orig1s000ltr.pdf",
              "date": "20160802",
              "type": "Letter"
            },
            {
              "id": "19993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208401s000lbl.pdf",
              "date": "20160802",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170728",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49153",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208401s002lbl.pdf",
              "date": "20170731",
              "type": "Label"
            },
            {
              "id": "49185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208401Orig1s002ltr.pdf",
              "date": "20170802",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA208401",
      "sponsor_name": "AZURITY",
      "openfda": {
        "application_number": [
          "NDA208401"
        ],
        "brand_name": [
          "QBRELIS"
        ],
        "generic_name": [
          "LISINOPRIL"
        ],
        "manufacturer_name": [
          "Azurity Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "52652-3001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISINOPRIL"
        ],
        "rxcui": [
          "1806884",
          "1806890"
        ],
        "spl_id": [
          "461e97d5-c8b3-75a7-e063-6394a90a6ec6"
        ],
        "spl_set_id": [
          "9f6e4e57-a489-4b36-b093-b93865d3717c"
        ],
        "package_ndc": [
          "52652-3001-1"
        ],
        "unii": [
          "E7199S1YWR"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "QBRELIS",
          "active_ingredients": [
            {
              "name": "LISINOPRIL",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}